Pelvic Floor Prolapse Clinical Trial
Official title:
The Effect of Intravaginal Conjugated Estrogen on Ring Pessary Use for Pelvic Organ Prolapse: A Multicenter Randomized, Double- Blind, Placebo Controlled, Clinical Trial
The primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (POP) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.
Status | Not yet recruiting |
Enrollment | 420 |
Est. completion date | September 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Symptomatic POP, stage II, stage III or stage IV 2. Postmenopausal women (patients with serum FSH>40lu/L; or amenorrhea for 12 months) 3. Successfully fit with ring with support pessary 4. Ability to attend the clinical trial and follow-up 5. Patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent 6. Willing and able to place vaginal cream Exclusion Criteria: 1. Acute infection of internal genital tract 2. Hormone replacement therapy in recent 3 months 3. Suspected or untreated lower genital tract tumor 4. Genital fistula 5. Abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc) 6. Life expectancy less than 1 year 7. Vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium=5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer 8. The volume of post-voiding residual is more than 250ml. - |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Peking Union Medical College Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of subjects using the pessary and have very much or much improvement on the patient impression of improvement questionnaire at 1 year between the vaginal estrogen group and the placebo group. | Sustained wearing with satisfaction: continuous wearing is defined as the use of the pessary after successful fitting test. The continuous wearing time interval is from the start of wearing the pessary to cessation of pessary use. PGI-I (patient global impression of improvement))is used to evaluate patient impression of improvement. PGI-I is divided into seven levels: very much better, much better, a little bit better, no change, a little bit worse, much worse and very much worse. The patient's response of" very much better" and" much better" is defined as a successful impression of improvement. |
up to 1year after randomization | |
Secondary | 1. Comparison of symptom specific distress (PFDI-20) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year. | Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Floor Distress Inventory-20 ?PFDI-20 scores 0-300, The higher the score is, the more serious the symptoms of PFD are, the greater the impact on the life of the patients. | up to 1year after randomization | |
Secondary | 1. Comparison of symptom specific impact (PFIQ-7) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year. | Questionnaire survey: Relief of symptoms using validated instruments, pelvic floor impact questionnaire short form 7(PFIQ-7)?PFIQ-7 scores 0-300, the higher the severer negative influence on patient. | up to 1year after randomization | |
Secondary | 1. Comparison of sexual function (PISQ-12) at 6 months and one year in subjects using the pessary in the vaginal estrogen group and the placebo group at 1 year. | Questionnaire survey: Relief of symptoms using validated instruments, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form(PISQ-12), PISQ-12 scores 0-48, the higher, the severer negative influence on patient. | up to 1year after randomization | |
Secondary | Comparison of the adverse events of subjects wearing a pessary in the vaginal estrogen group and the placebo group at 1 year. | Complications will be asked and reported during each follow-up | up to 1year after randomization |
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